Reported Nov 29, 2023 · Ongoing
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include
SunMed Holdings, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SunMed Holdings, LLC · 2710 Northridge Dr Nw Ste A · Grand Rapids, MI · 49544-9112
Is this the product you have?
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include
5 of 5 products
| Model / number | Product as published |
|---|---|
2442-BVMPAD | Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask |
2442-BVMPCH | Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask |
2442-BVMCIN | Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask |
2442-BVMPIN | Curaplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks |
2442-BVMPSA. | Curaplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks |
- Amount recalled
- N/A
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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